EndometriosisNCT04159740
Microbiome and Immunologic Analysis - Women With Endometriosis
An observational study of Endometriosis, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary goal of this study is to assess differences in the microbiome between women with and without endometriosis. A second goal of this study is to assess immunologic differences between the eutopic (within the uterus) and ectopic (outside of the uterus) endometrial tissue in women with endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Tissue and blood collection
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2020to 11 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Premenopausal women with or without endometriosis, planning to undergo laparoscopic surgery for non-cancer indications.
Who may be able to join
- Females, age 18 years or older
- Undergoing laparoscopy (conventional or robotic) with or without hysterectomy for non-cancer indications and including women from two groups:
- Suspected endometriosis
- Elective salpingectomy or tubal ligation or abnormal uterine bleeding
- Understands study procedures
- Willing and able to provide signed informed consent
Who cannot join
- Postmenopausal
- Currently pregnant or lactating
- Prior hysterectomy or oophorectomy
- Undergoing hysterectomy via vaginal or abdominal approach
- Undergoing hysterectomy or laparoscopy for suspected malignancy
- Use of antibiotics within 2 weeks prior to surgery
Show all 9Show fewer
- Use of hormone therapy for endometriosis or contraception within 4 weeks prior to surgery
- Diagnosis or treatment of vaginitis during the past 6 months prior to surgery
- Personal history of autoimmune or inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbiome and Immunologic Analysis of the Lower and Upper Female Reproductive Tract in Women With Endometriosis
The primary goal of this study is to assess differences in the microbiome between women with and without endometriosis.
A second goal of this study is to assess immunologic differences between the eutopic (within the uterus) and ectopic (outside of the uterus) endometrial tissue in women with endometriosis.
In order to investigate these areas of interest, 25 women with endometriosis and 25 women without endometriosis will be enrolled. All women will be undergoing a previously scheduled surgical procedure at which time presence or absence of endometriosis will be confirmed and specimens will be obtained.
Read the detailed description
Endometriosis is a chronic gynecologic condition where implants of endometrial glands and stroma are present outside of the uterus. It occurs in 6-10% of women of reproductive age and is characterized by dysmenorrhea, chronic pelvic pain, dyspareunia, or infertility. In addition to symptom burden, there are significant direct costs related to diagnosis and treatment of disease, as well as indirect costs related to absenteeism from school and work, loss of productivity, and unemployment. The estimated national economic burden in the United States related to these costs is approximately 78 billion dollars per year. While clinical signs and symptoms may be suggestive of endometriosis, the gold standard for diagnosis requires surgical confirmation of disease.
The pathogenesis of endometriosis is complex and likely multifactorial with genetic, epigenetic, environmental, and immunologic factors. An increasing number of studies have also suggested the role of the microbiome in human health and development of disease. This study aims to investigate possible differences in the microbiome and immunologic factors that could contribute to pathogenesis of this disease. Findings from this study could potentially contribute to the development of of a less invasive, non-surgical diagnostic test for endometriosis.
- Conditions
- Endometriosis
- Being tested
- Tissue and blood collection
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue and blood collectionOther
Tissue and swab (cells) collection for microbiome analysis. Blood collection for immune markers.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis - Cases | Premenopausal women with suspected endometriosis, planning to undergo laparoscopic surgery. Receives: Other: Tissue and blood collection | |
| Controls | Premenopausal women without endometriosis, planning to undergo laparoscopic surgery for non-cancer indications including elective salpingectomy, tubal ligation or surgical procedures for abnormal uterine bleeding Receives: Other: Tissue and blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome composition in genital tract and gastrointestinal tract
Measured: At time of surgery
Secondary outcomes (1)
Immunostaining of eutopic and ectopic endometrium for immune factors, immune cells, and fibrosis
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start6 Feb 2020
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina R. Walther-Antonio, Mayo Clinic
- Investigators
- Marina R Walther-Antonio, Ph.D., Principal investigator, Mayo ClinicAdela G Cope, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159740
- Sponsor's protocol ID
- 18-011885
- Status last verified
- Feb 2023
- First submitted
- 8 Nov 2019
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome and Immunologic Analysis of the Lower and Upper Female Reproductive Tract in Women With Endometriosis
- ClinicalTrials.gov ID
- NCT04159740
- Acronym / sponsor ID
- 18-011885
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of this study is to assess differences in the microbiome between women with and without endometriosis.
A second goal of this study is to assess immunologic differences between the eutopic (within the uterus) and ectopic (outside of the uterus) endometrial tissue in women with endometriosis.
In order to investigate these areas of interest, 25 women with endometriosis and 25 women without endometriosis will be enrolled. All women will be undergoing a previously scheduled surgical procedure at which time presence or absence of endometriosis will be confirmed and specimens will be obtained.
Detailed description
Endometriosis is a chronic gynecologic condition where implants of endometrial glands and stroma are present outside of the uterus. It occurs in 6-10% of women of reproductive age and is characterized by dysmenorrhea, chronic pelvic pain, dyspareunia, or infertility. In addition to symptom burden, there are significant direct costs related to diagnosis and treatment of disease, as well as indirect costs related to absenteeism from school and work, loss of productivity, and unemployment. The estimated national economic burden in the United States related to these costs is approximately 78 billion dollars per year. While clinical signs and symptoms may be suggestive of endometriosis, the gold standard for diagnosis requires surgical confirmation of disease.
The pathogenesis of endometriosis is complex and likely multifactorial with genetic, epigenetic, environmental, and immunologic factors. An increasing number of studies have also suggested the role of the microbiome in human health and development of disease. This study aims to investigate possible differences in the microbiome and immunologic factors that could contribute to pathogenesis of this disease. Findings from this study could potentially contribute to the development of of a less invasive, non-surgical diagnostic test for endometriosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis - Cases | – | Other: Tissue and blood collectionPremenopausal women with suspected endometriosis, planning to undergo laparoscopic surgery. |
| Controls | – | Other: Tissue and blood collectionPremenopausal women without endometriosis, planning to undergo laparoscopic surgery for non-cancer indications including elective salpingectomy, tubal ligation or surgical procedures for abnormal uterine bleeding |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Premenopausal women with or without endometriosis, planning to undergo laparoscopic surgery for non-cancer indications.
Key inclusion criteria (6 listed)
- Females, age 18 years or older
- Undergoing laparoscopy (conventional or robotic) with or without hysterectomy for non-cancer indications and including women from two groups:
- Suspected endometriosis
- Elective salpingectomy or tubal ligation or abnormal uterine bleeding
- Understands study procedures
Key exclusion criteria (9 listed)
- Postmenopausal
- Currently pregnant or lactating
- Prior hysterectomy or oophorectomy
- Undergoing hysterectomy via vaginal or abdominal approach
- Undergoing hysterectomy or laparoscopy for suspected malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue and blood collectionTissue and swab (cells) collection for microbiome analysis. Blood collection for immune markers. | Other | Controls, Endometriosis - Cases |
Primary outcome
Microbiome composition in genital tract and gastrointestinal tract
Time frame: At time of surgery
1 secondary outcome
Immunostaining of eutopic and ectopic endometrium for immune factors, immune cells, and fibrosis
Time frame: At time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina R Walther-Antonio, Ph.D. principal investigator
Mayo Clinic
Adela G Cope, M.D. study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome composition in genital tract and gastrointestinal tract (time frame: At time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.